Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/0816—Measuring devices for examining respiratory frequency
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
  • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0057—Pumps therefor
  • A61M16/0066—Blowers or centrifugal pumps
  • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
  • A61M16/022—Control means therefor
  • A61M16/024—Control means therefor including calculation means, e.g. using a processor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/18—General characteristics of the apparatus with alarm
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3303—Using a biosensor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
  • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
  • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
  • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
  • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2230/00—Measuring parameters of the user
  • A61M2230/40—Respiratory characteristics
  • A61M2230/42—Rate

Definitions

• the present invention relates to the field of respiratory assistance systems for patients suffering from respiratory insufficiency or sleep apnea syndrome and in particular a method and a device for detecting an aggravation of the respiratory state of a patient treated by such a device.
• Non-invasive ventilatory support for long-term positive pressure at home has become a treatment modality that is increasingly used in patients with chronic respiratory and heart failure.
• Ventilatory Support is a medical device that is capable of infusing airflow (with or without oxygen) into a patient's airway to manage partially or totally his breathing effort. This device is used either through a mask placed on the nose and / or mouth (non-invasive ventilatory support), or via a tracheostomy cannula (invasive ventilatory support).
• This ventilatory support treatment can reduce these rapid and brutal aggravations, improve the quality of life and in certain respiratory insufficiencies survival.
• Recent known ventilatory support devices are equipped with embedded software that provides details on daily use (treatment compliance), and on a number of ventilatory parameters measured during treatment (minute ventilation, tidal volume, respiratory rate). leaks, patient initiated cycles, etc.). Current telecommunications technologies allow these parameters to be tele-transmitted to the clinician or home care provider in charge of the patient.
• a third object of the present invention is to provide a method constantly performing dynamic analysis of data from ventilatory support devices.
• a method for detecting an aggravation of the cardiorespiratory state of a patient treated with a respiratory assistance device comprising means for collecting and processing representative parameters:
• a first parameter representative of the respiratory rate of the patient on a first observation window for example daily
• a second parameter representative of the percentage of cycles triggered by the patient during a second observation window for example daily
• a third parameter representative of the duration of use of the apparatus during a third observation window for example daily.
• n days detecting a significant variation of one of said parameters for at least two consecutive or nonconsecutive days during a consecutive period of n days, with n strictly greater than 3 and preferably greater than 5;
• the method is directly implemented within the respiratory assistance device which is completely autonomous to generate alerts to the patient.
• the method is implemented within a remote server receiving by teletransmission the parameters of the respiratory assistance device for the purpose of their statistical analysis and, finally, the generation of a detailed alert during detection.
• the warning signal takes the form of a light signal that is displayed on the respiratory assistance device or an electronic mail destined for a messenger or an SMS destined for a mobile phone, which may be the mobile phone of the patient, his doctor, or any third health professional or health organization in charge of patient monitoring
• the threshold values used for the detection of a potential increase of the parameters considered are quartiles continuously updated as the new values acquired by the method, and the alert is automatically generated during the detection of :
• the invention also allows the realization of a self-contained breathing assistance device comprising:
• a ventilator for supporting the breathing of a patient
• a measuring system and sensors for collecting parameters and operating data of the device and in particular:
• a first parameter representative of the respiratory rate of the patient on a first observation window for example daily
• a second parameter representative of the percentage of cycles triggered by the patient during a second observation window for example daily
• a third parameter representative of the duration of use of the apparatus during a third observation window for example daily
• the invention makes it possible to provide a respiratory assistance device suitable for being integrated into a communication network, the device comprising communication means making it possible, on the one hand, to transmit said parameters to a remote server and, on the other hand, to on the other hand, receiving a control signal from said remote server for generation a warning signal, sound or light, intended to alert the patient or a practitioner in charge of the patient of a risk of worsening of his cardiorespiratory state.
• the invention allows the realization of a remote server adapted for communication with a respiratory assistance device, the remote server being adapted to the reception by remote transmission of the following representative parameters:
• the respiratory rate of the patient during a first observation window for example daily
• the duration of use of the apparatus during a third observation window for example daily.
• the server further comprises calculation means for detecting a significant variation of one of said parameters for at least two consecutive or non-consecutive days during a consecutive period of n days, with n strictly greater than 3 and preferably> 5;
• Figure 1 shows a block diagram of an embodiment of a medical assistance device according to the present invention.
• Figure 2 illustrates a general architecture of a medical respiratory assistance device integrated in a network context, allowing communication with a server via the Internet.
• Figure 3 illustrates an embodiment of the treatment method for the respiratory rate parameter and the percentage of cycles triggered by the patient.
• FIG. 4 illustrates an embodiment of the treatment method for the parameter corresponding to the observance or the duration of use of the respiratory assistance device.
• FIG. 5 illustrates an example of data representative of the respiratory rate and the detection of a so-called high value, greater than the third quartile.
• FIG. 6 illustrates an exemplary calculation of the quartiles of the respiratory rate recorded by the device in the embodiment described.
• FIG. 7 illustrates an example of data representative of the duration of use and the detection of values HIGH and LOW, respectively greater than the third quartile Q3 and lower than the first quartile Q1.
• Figure 8 illustrates an example of calculating the quartiles of the duration of use.
• the invention can be adapted to any medical invasive or non-invasive ventilation device.
• a non-invasive device - VNI - the endotracheal approach (intubation or tracheostomy) is not used.
• such a medical respiratory assistance device is schematically represented in FIG. 1 under the reference 100, and comprises a conventional ventilator 10, connected to a power source for operation or autonomous thanks to a battery, optionally associated with an oxygen supply source 30, under the control of a control and treatment unit 40.
• the ventilator 10 blows air (enriched or not with oxygen) to the lungs of a patient through a conduit system 20 under the control of a microprocessor located within the control unit 40, allowing different levels of adjustments in the distribution of the breathing assistance and oxygen.
• the fan 10 is capable of operating in several conventional modes of operation well known to those skilled in the art, which need not be further described.
• the device 100 further comprises a display 70 and optionally a user interface 80 for the patient, as well as a measurement and sensor system 50 which is equipped with conventional measuring means, in particular flow and / or pressure, allowing collect multiple information and data for the control unit 40 and useful for the operation of the respiratory assistance system 100 according to protocols well known to those skilled in the art.
• the measurement and sensor system 50 also allows, together with the control and treatment unit 40, the collection of multiple measured information and ventilatory parameters (minute ventilation, tidal volume, respiratory frequency, leakage, cycles triggered by the patient, etc.) that will be used in the analysis process used for the early detection of an exacerbation, including at least one of the following three parameters: a first parameter representative of the respiratory rate on a first observation window, for example daily;
• a second parameter representative of the percentage of cycles triggered by the patient during a second observation window for example daily
• a third parameter representative of the duration of use of the apparatus during a third observation window for example daily
• these parameters can be calculated in various ways, in particular from an algebraic average or by a median calculation.
• At least one of these three parameters can usefully be used for a fine statistical analysis for early detection of a potential aggravation.
• the analysis and detection method that will be described below is implemented locally, within the respiratory assistance device itself, and by requesting the data processing device.
• the control and processing unit 40 processor, internal memory, etc.
• the method of analysis and detection is the subject of a remote processing carried out via a remote server - such as the server 240 of Figure 2 for example - based on the remote remote transmission of parameters above through the communication unit 60 illustrated in FIG.
• this communication unit 60 will be a modem allowing access to the Internet through the telephone line.
• the communication unit may comprise a communication device compliant with the IEEE 802.1 1 (Wi-Fi) standard allowing direct access to a wireless network and, consequently, to the Internet network via a gateway dedicated.
• Wi-Fi IEEE 802.1 1
• the respiratory assistance device 100 may be provided with a communication unit based on mobile telephony, allowing low-speed (GSM, GPRS) or high-speed (3G, 4G) data communication according to the case.
• the communication unit 60 allows the upstream transmission of data and parameters resulting from the operation of the device and, in the downward direction, the reception of control instructions from a remote server. .
• FIG. 2 more particularly illustrates an embodiment of a respiratory assistance device 100 configured to be integrated within a larger telecommunications network, comprising the Internet network 200 with which the device 100 is able to communicate thanks to the communication unit 60, in particular to access a secure remote server 240, which may be the server of the manufacturer of the device 100 or any remote server storing and processing the data collected within the device 100, possibly in an anonymous form if the server only has the serial number of the device 100.
• the communication between the device 100 and the server 240 can take various forms permitted by the various TCP / IP communication protocols and specifically, if necessary, the HTTP protocol (shown in Figure 2) or its secure version HTTPs widely used by Internet browser software.
• a third-party server 250 communicating with the remote server 240 of the manufacturer of respiratory assistance equipment (and communicating, for example, according to a client / server TCP / IP architecture ) or communicating even directly with the medical device respiratory assistance 100.
• the third server 250 may be, by way of illustration but not limited to, the server of a medical-technical structure intervening for example as a reinforcement of a hospital service and providing its assistance and / or technical expertise for the deployment of respiratory assistance equipment at the patients' homes.
• the network can also integrate the patient's communication devices, as is illustrated in FIG. 2 with a laptop 210 communicating directly with the Internet network and a smart mobile phone 220 (called "smartphone" in the Anglo-American literature). - Saxon) also enabling communication via the Internet through a data link with its base station 260.
• the network Even integrates the communication tools of the practitioner or clinician, as illustrated by the computer 230 of Figure 2.
• a first parameter representative of the respiratory rate on a first observation window for example daily
• a second parameter representative of the percentage of cycles triggered by the patient during a second observation window for example daily
• a third parameter representative of the duration of use of the apparatus during a third observation window for example daily
• the method allows early detection of the risk of exacerbation with data transmitted to the third party responsible for the medical and paramedical supervision of the patient, thus offering the patient an opportunity to quickly consult his practitioner who can take the necessary preventive measures and thereby reduce the case. the risk of a heavy and expensive hospitalization.
• the method leads to the automatic generation of an alert message for the attention of the patient or the attention of a practitioner or a third party health professional authorized to receive such messages, as soon as a significant variation of one of the three preceding parameters is detected for at least two consecutive or non-consecutive days during a consecutive period of n days, with n strictly greater than 3 and more particularly greater than 5 and preferably equal to five days.
• the method For the respiratory rate and / or the percentage of cycles triggered by the patient, the method comprises the following steps, illustrated in FIG.
• Step 301 measurement of the parameter considered, ie either the respiratory rate or the percentage of cycles triggered;
• Step 302 integration of the measured value of the parameter under consideration into a population of distributed values in q intervals defined by (q-1) q-quantiles;
• Step 303 generating a value representative of the parameter considered for the observation window considered, for example the daily window;
• Step 304 comparing the value generated in step 303 with the value of a q-quantile greater than the median corresponding to a previous observation window, to determine a potential value HIGH;
• Step 305 generating a signal or warning message in the event of detection of two consecutive HIGH or non-consecutive values during a period of n consecutive days, with strictly greater than 3 and preferably n> 5.
• the method comprises the following steps, illustrated in FIG.
• Step 401 measurement of the duration of use for the observation window considered, for example daily;
• Step 402 integrating the measured value into a population of distributed values in q intervals defined by (q-1) q-quantiles;
• Step 403 comparison of the value measured for the observation window with the value of two quartiles corresponding to windows of previous observations, respectively less than and greater than the median, for the purpose of determining two values, respectively LOW and HIGH ;
• Step 404 generating a signal or warning message if at least three HIGH and / or LOW values are detected, consecutive or non-consecutive, during a period of n days, with n> 5.
• the values measured and collected by the measurement and sensor unit 50 can be used for the automatic generation of an alert for the patient or his practitioner that can take any form, including the most varied in the context of a respiratory assistance device 100 integrated within a communication network, It may first be a simple visual or audible alert broadcast by the device 100 - for example a visual message broadcast on the display 70 - in response to receiving a specific command received from the remote server 240 (see third party server 250). Alternatively, it may be an explicit e-mail, transmitted on the electronic mail system 210 of the patient or his practitioner, or received by SMS on the mobile phone 220 of the patient or practitioner.
• the threshold values used for the detection of a potential increase in the parameters considered are percentiles of the established reference values (75 th or> at the 3 rd quartile) continuously updated as the new values acquired by the process, and the alert is automatically generated when thresholds are detected.
• the observation window is a daily window and the population of values measured is distributed in quartiles, so that the alert message is automatically generated as soon as one of the following three situations is detected:
• a server 240 (or 250) is also configured that is specifically prepared to communicate with a respiratory assistance device as previously described and illustrated in FIG. 1, and adapted for reception by remote transmission. following representative parameters:
• the respiratory rate of the patient during a first observation window for example daily
• the percentage of cycles triggered by the patient during a second observation window for example daily
• the duration of use of the apparatus during a third observation window for example daily.
• the server is configured to generate an alert message to the respiratory assistance device 100, or an email / SMS to one of the 210-220-230 systems.
• FIG. 5 illustrates an example of data representative of the respiratory rate and the detection of a so-called high value, greater than the third quartile.
• the respiratory rate recorded by these devices corresponds to the number of times / minute or the device generates an insufflation rate to the patient. This respiratory rate expressed in cycles / minute is expressed as its average or median value per day depending on the different manufacturers present on the market.
• the method includes detecting a respiratory rate that will be classified as "HIGH" value for at least two days (consecutive or not) in a five-day period. A respiratory rate is rated "HIGH" one day if it is greater than the 3rd quartile of the respiratory rates recorded by the device until the day before, as shown in Figure 5.
• FIG. 6 illustrates an exemplary calculation of the quartiles of the respiratory rate recorded by the device in the embodiment described. It can be seen that the calculation of the 3 rd quartile of the respiratory rate requires at least four consecutive recording days. It is then recalculated daily taking into account each day of use of the device. This is only a practical example of achievement. In a similar way, the percentage of cycles triggered by the patient is analyzed. As has been described, the respiratory rate recorded by the ventilatory assist devices represents the number of cycles / minute that the device generates to the patient. Each cycle can either be triggered by the patient himself or triggered by the device if the patient's trigger rate is lower than the preprogrammed frequency in the device.
• the ratio of the number of cycles triggered by the patient to the total number of cycles delivered by the device represents "the percentage of cycles triggered”. This variable is reported (average or median) per day of use.
• Example A subject that triggers all respiratory cycles of the device will have a percentage of cycles triggered at 100%.
• a patient who triggers half of the cycles and the other half is generated automatically by the device will have a percentage of cycles triggered at 50%.
• the percentage of the cycles triggered by the patient is analyzed as the respiratory rate previously described:
• the method consists in detecting the percentage of triggered cycles which will be classified as "HIGH" value for at least two days (consecutive or not) in a five-day period.
• the percentage of cycles triggered is rated "HIGH" one day if it is greater than the 3rd quartile of the percentages of triggered cycles recorded by the device until the day before.
• the calculation of the 3rd quartile of the percentage of cycles triggered is identical to that of the respiratory rate.
• FIG. 7 illustrates an example of data representative of the duration of use and the detection of values HIGH and LOW, respectively greater than the third quartile Q3 and lower than the first quartile Q1.
• the daily usage time is recorded by ventilatory support devices (usage schedule). It is reported in hours: minutes / day.
• the duration of daily use is analyzed as described above and, as seen in Figure 7, is to detect a daily life "HIGH” or "LOW” at least two days - and preferably three days - consecutive or not - per period of at least five days.
• the daily usage time is classified as "HIGH" value one day if it is greater than the third quartile of the daily usage times recorded by the device up to two days before.
• the daily life is rated "Low” one day if it is less than the first quartile of daily usage times recorded by the device up to two days before ( Figure 7).

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• 2014
  • 2014-06-05 FR FR1401297A patent/FR3021872B1/fr not_active Expired - Fee Related
• 2015
  • 2015-06-04 JP JP2017516200A patent/JP2017524489A/ja active Pending
  • 2015-06-04 EP EP15725673.6A patent/EP3151747A1/fr not_active Withdrawn
  • 2015-06-04 WO PCT/EP2015/062529 patent/WO2015185703A1/fr active Application Filing
  • 2015-06-04 CN CN201580042116.4A patent/CN106793975B/zh not_active Expired - Fee Related
  • 2015-06-04 US US15/316,278 patent/US20180184945A1/en not_active Abandoned

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